Duane Morris Products Liability

October 13, 2023 by Duane Morris

Why Talc Claimants’ Experts Should Fear New Jersey Courts

Sharon Caffrey, co-chair of Duane Morris’ Trial Practice Group, is quoted in the Law360 article “Why Talc Claimants’ Experts Should Fear New Jersey Courts.”

From the article:

Cleavage fragments, or mineral particles that are found in rocks, can look like asbestos chemically, but they don’t have the same cancer-causing fibrogenic characteristics that asbestos does, Duane Morris LLP partner Sharon Caffrey told Law360.

“It’s not asbestos, and it’s … never been established as a cause of mesothelioma,” Caffrey said.

Visit the Law360 website to read the full article.

October 5, 2023 by Duane Morris

After MoCRA, Federal Cosmetics Regulatory Laws Due Overhaul

On December 23, 2022, Congress enacted the Modernization of Cosmetics Regulation Act (MoCRA)—the first major statutory change to the U.S. federal government’s ability to regulate cosmetics since 1938. Passed with bipartisan
and industry support, MoCRA expands the Food and Drug Administration’s authority over cosmetics, and creates substantial new obligations for manufacturers, packers and distributors of cosmetics intended for sale in
the United States. Here’s what beauty companies need to know.

To read the full text of this article by Duane Morris attorney Kelly Bonner, please visit the firm website,

September 27, 2023September 27, 2023 by Will Heaston

FDA Releases New Draft Guidance Documents to Modernize the 510(k) Process

On September 6, 2023, the FDA released three draft guidance documents that seek to “modernize” the 510(k) premarket notification process. Ever since the FDA first proposed “transformative new steps” to the program in 2018, the agency has promised to further update the 510(k) clearance pathway in an effort to better balance technological innovation and patient safety. In issuing these draft guidance documents, the FDA has followed through on that promise.

Continue reading “FDA Releases New Draft Guidance Documents to Modernize the 510(k) Process”

August 16, 2023 by Duane Morris

FDA Draft Guidance Recommends Info to Include in Patient-Matched Guides to Orthopedic Implants

This summer, the U.S. Food and Drug Administration (FDA) issued draft guidance regarding patient-matched guides to orthopedic implants, which are intended to assist in the execution of a pre-surgical plan concurred upon by the patient’s healthcare professional to position an orthopedic implant in a way consistent with the implant’s indicated use. In the draft guidance, FDA recommends information to include in pre-market submissions for patient-matched guides to orthopedic implants. FDA also suggests information for manufacturers to consider when creating the design process for patient-matched guides.

View the full Alert on the Duane Morris LLP website.

August 10, 2023 by Duane Morris

FDA Issues New Nitrosamine Impurities Guidance

By Alan Klein, Patrick Gallagher and Michael Fox

On August 4, 2023, the FDA issued a new Guidance to the pharmaceutical industry relating to large molecule drugs left unaddressed in its earlier nitrosamine Guidance publications. (Access the complete Guidance or the abbreviated version.)

Reacting to considerable input from the pharmaceutical industry, both brand and generic, following the agency’s Federal Register request for and receipt of extensive comments on these issues, including scientific data furnished to the agency by NDA and ANDA sponsors over the past year and a half, FDA has now provided drug manufacturers with critical guidelines for conforming their products to what the agency has determined to be safe nitrosamine exposure limits for patients. This comes on the heels of setting similar exposure limits for these products late last month by the European Union’s chief drug regulator, the European Medicines Agency. In its current Guideline, FDA has ranked impacted prescription drugs into 5 categories depending upon their carcinogenic potency, with “1” being the most potent, and “5” the least. Instructing the industry on their responsibility to minimize or eliminate nitrosamine impurities in their products to the extent feasible, the agency has extended the timeline for this task to August 2025, recognizing the complexity of this process and the need to avoid recalls and market disruptions of widely prescribed and important medications.

July 26, 2023July 28, 2023 by Duane Morris

Business of Fashion Article Quotes Duane Morris Attorney Kelly Bonner

Duane Morris attorney Kelly A. Bonner was quoted in an article in The Business of Fashion titled “What Beauty Needs to Know About the Biggest New Regulations in 80 Years,” about the Modernization of Cosmetics Regulations Act (MoCRA) recently signed into law. To read the full text of this article, please visit the firm website.

July 6, 2023 by Duane Morris

Regulatory Compliance Checklist Post-MoCRA for Beauty and Personal Care Products

MoCRA, Pub. L. No. 117-328, represents the first major statutory change to the authority of the Food and Drug Administration (FDA) to regulate cosmetics since the Food, Drug, and Cosmetics Act (FDCA), 21 U.S.C. § 361 et seq., in 1938 and the Fair Packaging and Labeling Act (FPLA), 21 C.F.R. § 701.3, in 1966.

This checklist outlines key regulatory compliance considerations that are specific to personal care products marketed in the United States following the enactment of the federal Modernization of Cosmetics Regulation Act (MoCRA) on December 23, 2022.

To read the full text of this Lexis Nexis Practical Guidance Checklist by Duane Morris attorneys Driscoll Ugarte, Rick Ball, Alyson Lotman, Kelly Bonner and Coleen Hill, please visit the firm website.

June 7, 2023June 8, 2023 by Robert Kum

Explosion of Silica Exposure-Related Lawsuits in California

Silica is an abundant mineral found in materials including sand, stone, and concrete. While serving as a principal component of glass, cement, and ceramics, silica also presents an increasingly pertinent issue for those with interests in toxic torts, as well as businesses involved in the manufacturing or distribution of silica products: occupational exposure to airborne silica, a leading cause of silicosis and lung cancer.

Silicosis is a severe, incurable lung disease that is often fatal. Upon inhalation of fine particles created through workers’ manipulation of the material, small amounts of silica become trapped in the lungs, causing the scarring of lung tissue. Resulting effects are severe, often requiring lifelong care and a possible lung transplant.

Cases commonly appear among those working in construction or mining, and symptoms can present after only a few years of occupational exposure. More often than not, workers use little to no protective equipment, leaving them vulnerable to inhalation of the harmful substance. With the number of silicosis cases on the rise, the issue has been denoted an “emerging epidemic” constituting a “public health problem of great urgency.”[1]

California has recently seen a large cluster of occupational-related silicosis cases, with its Department of Public Health identifying at least sixty-nine confirmed cases since 2019. And the primary victim? Fabricators and installers of artificial-stone countertops. Continue reading “Explosion of Silica Exposure-Related Lawsuits in California”

April 11, 2023 by Duane Morris

Pa. Supreme Court Can Finally Set Proper Venue Standards

In March, the Pennsylvania Supreme Court heard oral argument in Hangey v. Husqvarna on the standards governing venue in a product liability case.

The court’s decision, expected by the end of the year, may provide important guidance on just how much business a corporate defendant must undertake in a plaintiff’s chosen forum for venue to attach.

This article will describe the case on appeal, the venue issues it raises and the precedential context in which it finds itself. We will also suggest a few important takeaways as trial courts and litigants await the disposition of the appeal.

To read the full text of this article by Duane Morris attorneys Alan Klein and Ethan Feldman, please visit the firm website.

February 22, 2023February 23, 2023 by Duane Morris

Following MOCRA’s Enactment, Unpacking Litigation and Regulatory Risk for Cosmetics Brands

On December 23, 2022, Congress enacted the first major statutory change to the Food and Drug Administration (FDA)’s ability to regulate cosmetics since the Federal Food, Drug, and Cosmetic Act (FDCA). Passed with bipartisan and industry support, the Modernization of Cosmetics Regulation Act (MoCRA) significantly expands FDA’s rulemaking and enforcement authority over cosmetics and creates substantial new compliance obligations for manufacturers, packers, and distributors of cosmetics intended for sale in the United States.

Although MoCRA establishes several new requirements concerning product safety, it provides comparatively little guidance on the kinds of marketing or promotional claims brands can now make about the safety of their products.

To read the full text of this article by Duane Morris attorneys Rick Ball, Alyson Walker Lotman and Kelly Bonner, please visit the Duane Morris website.